Inspiratory Muscle Training in People With Long COVID-19- A Pilot Investigation.
- Conditions
- Long COVID
- Interventions
- Device: PrO2
- Registration Number
- NCT06091358
- Lead Sponsor
- University of Bath
- Brief Summary
This pilot investigation will recruit people with Long COVID to participate in a 4 week individualized inspiratory muscle training intervention with pre and post spirometry testing and additional functional outcomes to assess the effectiveness of the intervention.
- Detailed Description
The study design is a 4 - week parallel-arm intervention, randomised controlled trial. Participants will attend 2 testing days, baseline and follow-up 4 weeks apart.
Participants will first be screened over the phone to assess eligibility. Participants will then be randomly allocated using minimisation, into either control or intervention arm.
Baseline testing:
Participants will undergo baseline testing in the laboratory.
Participants will be measured for their anthropometrics; height and weight. Participants will complete a series of questionnaires for 15 mins.
Following 15 minutes rest, participants will then have three resting blood pressure and heart rate measurements and averaged via a sphygmomanometer and polar HR watch.
MIP will be measured using the MicroRPM care fusion 3 times and the highest value reported (10 minutes). Forced expiratory value in 1 second (FEV1) and peak expiratory flow (PEF) will be measured using Vitalograph 700 (Spirotrac 6).
Participants will undergo a 6-minute-walk-test self-paced where Rating of perceived exertion (RPE) and Borg dyspnea scale (BDS) will be assessed each minute. Then a sub-maximal exercise test using a cycle ergometer and VyntusCPX, where Ventilatory threshold (VT) and Maximal heart rate (HRMax)will be measured. Participants will be asked to cycle until they reach a 17 RPE on a ramp test of 10-15W/min (\>20mins). Heart rate (HR), Rating percieved exertion (RPE) and Borg dyspnea scale BDS) measured each minute.
The intervention arm will receive a handheld PrO2 device and will participate in two unsupervised sessions and one supervised via Microsoft teams sessions per week. Participants will complete 3 sessions per week, for 4 weeks. Each session will include 6 x 6 inspirations at 80% of MIP. MIP will be measured on the supervised session day. The control group will be asked to continue as normal throughout the 4 weeks.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 16
- Experiencing self reported Dyspnea (Breathlessness) following COVID-19 infection over 3 months ago.
- Aged between 18 and 65
- Are pregnant
- Receiving treatment following a previous cardiac event (Myocardial-infarction and Non-ST elevation MI),
- Have a dementia diagnosis,
- Have a high risk of falls,
- Have an additional chronic respiratory disease diagnosis such as (Chronic obstructive pulmonary disease) COPD or CF (cystic fibrosis)
- Are receiving respiratory muscle training
- Are receiving steroid inhaler treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inspiratory Muscle training intervention PrO2 Participants will arrive at the Laboratory and complete a series of questionnaires: general physical activity, BDI, TDI, PSQI, General health questionnaire, Post COVID fatigue scale, EQ 5D-5L. They will undergo spirometry testing FEV1, MIP and PEF. Participants will undergo a 6 minute walk test and a Sub-maximal exercise test (CPET) using a cycle ergometer (15W/min) until an RPE of 17. Participants undergo inspiratory muscle training for 4 weeks between baseline and follow up testing. They will be given a PrO2 device where the intervention will be 3 times per week for 4 weeks. Each session will be 6x6 breaths at 80% MIP. Participants will have 1 call per week where MIP is measured using a Care fusion hand held spirometer device. After 4 weeks, participants will return to the Laboratory and repeat baseline testing.
- Primary Outcome Measures
Name Time Method Change in Maximal inspiratory muscle pressure (MIP) at week 4. Baseline, and week 4 Maximal inspiratory muscle pressure (cmH20)
- Secondary Outcome Measures
Name Time Method Change in Peak expiratory flow (PEF) at week 4. Baseline, and week 4 Peak expiratory flow (PEF) (l/min)
Change in Ventilatory threshold (VT) at week 4. Baseline, and week 4 Ventilatory threshold (VT)
Change in 6 minute walk test distance at week 4 Baseline, and week 4 6 minute walk test difference (m)
Change in Forced ventilatory equivalent 1 second (FEV1) at week 4 Baseline, and week 4 Forced ventilatory equivalent 1 second (FEV1) (%)
Difference between Baseline Dyspnea Index score (BDI) and Transitional Dyspnea index (TDI). Baseline, and week 4 BDI and TDI
Trial Locations
- Locations (1)
The University of Bath
🇬🇧Bath, United Kingdom